syngo Imaging XS. Radiological image processing system.
FDA device recall Z-2264-2012 · posted 2012-08-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge Enhancement" and "Histograms".
- Action taken
- Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep..
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 52
- Distribution
- Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
- Date initiated
- 2012-07-18
- Date posted
- 2012-08-24
- Date terminated
- 2014-11-06
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNGO IMAGING XS (K082430) | Siemens AG Medical Solutions | 2008-11-14 |